510(k) Report

Devices descending from K142050

449 later devices reach Nuvasive Coroent Small Contoured Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200312Tryptik TiSpineart20202—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K191134IB3D AlifMedicrea International SA20191—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—